MalfunctionFCE
WALGREENS PERSONAL DOUCHE & ENEMA SYSTEM
Received Mar 11, 2003 · Event occurred Jan 26, 2003
Report 1520456-2003-00001 · MDR key 448176
Device
Generic name
Combination Douche/enema System
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
02123
Lot number
UNK
Product problems
- Sharp/jagged/rough/etched/scratched
Patient
*
- Laceration(s)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
RECTAL LACERATIONS DUE TO A SHARP EDGE ON THE PLASTIC TUBING OF A PERSONAL DOUCHE AND ENEMA SYSTEM. THE PT PURCHASED THE DEVICE FOR HOME USE. AFTER USING THE PRODUCT, THEY DISCOVERED THERE WAS A SHARP EDGE ON THE PLASTIC TUBING, CAUSING LACERATIONS TO THEIR RECTAL AREA. THE PT SOUGHT UNSPECIFIED MEDICAL ATTENTION AND TREATMENT.